Intercept (ICPT) Ocaliva Wins Positive CHMP Opinion for PBC

Intercept Pharmaceuticals, Inc.ICPT announced that that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval of Ocaliva (obeticholic acid/OCA) for the treatment of primary biliary cholangitis (PBC).

Note that the European Commission (EC) generally takes the CHMP’s opinion into account while reviewing drug applications but is not bound to abide by the same.

The positive opinion was based on efficacy and safety data from three randomized double-blind, placebo-controlled studies that evaluated the effect of OCA on alkaline phosphatase (ALP) and bilirubin in PBC patients.

However, Intercept is required to provide post-approval data from the safety and efficacy analyses of the ongoing phase IV COBALT study and a short-term study in patients with hepatic impairment.

We remind investors that in May 2016, Ocaliva, in combination with ursodeoxycholic acid (UDCA), was approved in the U.S. for the treatment of PBC in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

We note that UDCA is the only drug approved in the U.S. for PBC. PBC affects approximately one in 1,000 women aged over 40 years. Hence, there is significant unmet need for therapies in this space.

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